Person-Environment Fit for Persons With Dementia

NCT05722743 | Completed

• 2 other identifiers: 728931K23AG075262-01A1
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

This trial will assess feasibility of a non-pharmacological intervention for persons living with Alzheimer's disease and related dementias (ADRD) to improve behavioral and psychiatric symptoms of dementia and functional performance. Using a two-arm, prospective randomized controlled trial, 38 dyads (person with ADRD and caregiver) will complete an 8-week telehealth occupational therapy intervention provided via Zoom with caregivers and persons with dementia or receive an active control with 8 telehealth sessions to discuss publicly available caregiver education with a non-clinical research assistant.

Conditions

Dementia Alzheimers; Alzheimer Disease

Keywords

Behavioral; Occupational therapy; Alzheimer's disease and related dementias; Telehealth; Caregiver

Outcome Measures

Primary Outcomes (2)

• Change in patient performance as measured by Canadian Occupational Performance Measure (COPM)

  Criterion-referenced interview of patient performance with caregiver The COPM is a reliable and validated measure of performance in primary daily activities (self-care, leisure, productivity) with dyad-caregiver rated of performance and satisfaction. Scores are determined on a likert scale of 1-10 with 1 being lowest and 10 indicating highest of the topic of the question.

  13weeks (baseline, post-intervention, follow up)

• Caregiver satisfaction of patient performance [Feasibility]

  The primary outcome analysis is the feasibility of implementation as measured by caregiver satisfaction. The Canadian Occupational Performance Measure will measure caregiver satisfaction of patient performance, high scores indicate higher levels of satisfaction. Range 0-10.

  13 weeks (baseline, post intervention, follow up)

Secondary Outcomes (3)

• Zarit Caregiver Burden Scale

  13 weeks (baseline, post intervention, follow up)

• Neuropsychiatric Inventory Questionnaire (NPI-Q)

  13 weeks (baseline, post intervention, follow up)

• Functional Behavior Profile (FBP)

  13 weeks (baseline, post intervention, follow up)

Other Outcomes (5)

• Home Occupational Environment Assessment (HOEA)

  1 time (baseline)

• Adult Sensory Profile (ASP)

  1 time (baseline)

• Clinical Dementia Rating Scale (CDR-SUM)

  1 time (baseline)

Study Arms (2)

Harmony at HOME

EXPERIMENTAL

Participants in this group will receive the Harmony at HOME intervention.

Behavioral: Harmony at HOME

National Institute on Aging Program

ACTIVE COMPARATOR

Participants in this group will receive the National Institute on Aging education.

Behavioral: National Institute on Aging Program

Interventions

Harmony at HOME BEHAVIORAL

The Harmony at HOME (Help Online Modifying the Environment) intervention builds on prior successful foundations of dementia care interventions with a novel approach combining remote implementation, antecedent education, and home environment intervention. The intervention will teach caregivers how to 1) assess the home environment as an antecedent to behavior for the person with ADRD, and 2) design and implement individualized environmental modification through an environmental cueing approach to address the needs of the person with ADRD in a supportive environment.

Harmony at HOME

National Institute on Aging Program BEHAVIORAL

Standard of care will address behaviors and psychiatric symptoms of dementia (BPSD) for persons with ADRD, as recommended by their medical provider. Caregivers will receive training regarding home safety via a home safety handout based on National Institutes on Aging "Home Safety and Alzheimer's Disease" webpage.

National Institute on Aging Program

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women aged 60-99, inclusive.
• Living at home in the community with one primary caregiver.
• Diagnosis or probably diagnosis of dementia (confirmed by Clinical Dementia Rating Scale score of 1.0+)
• If on psychotropic medication, they are at a point where dosage and treatment are stabilized for the duration of the study.
• Functional sensory abilities with or without aids (hearing, vision, smell, touch, taste)
• Caregiver report of challenges related to behaviors within 4 weeks of study enrollment.
• Caregiver willing to participate throughout duration of study.
• Contact with University of Kentucky Alzheimer's Disease Research Center or Kentucky Neuroscience Institute medical provider within 12 months of study recruitment.
• Men or women aged 21-99, inclusive.
• Willingness to participate in study and implement recommended data collection tools.
• English speaking, able to read and write.
• Ability to retrieve and send mail.

You may not qualify if:

• Unstable medical conditions within one month prior to screening visit such as poorly controlled blood pressure, diabetes, current cancer diagnosis, or breathing problems, etc.
• Wheelchair or bed bound.
• Residence in skilled nursing facility or facility-based care.
• Caregiver report of physically violent behaviors.
• Initiation of antipsychotic medication within 4 weeks prior to screening or unpredictable use of such medications
• Diagnosis of profound or total sensory altering disorders including macular degeneration, legal blindness, total deafness, severe peripheral neuropathy, anosmia.
• Major depression in past 12 months (DSM-IV criteria), major mental illness such as schizophrenia, bipolar disorder, personality disorders, or recent (in past 12 months) alcohol or substance abuse.
• Major infection within 4 weeks prior to the Baseline Visit.
• Diagnosis of mild cognitive impairment or dementia.

Sponsors & Collaborators

• Elizabeth K Rhodus: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Behavior

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Elizabeth Rhodus, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 27, 2022
• First Posted: February 10, 2023
• Study Start: June 14, 2023
• Primary Completion: June 20, 2025
• Study Completion: June 20, 2025
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)